Quality and Manufacturing Engineering Lead

Quality & Manufacturing Engineering Lead
On-site, Greater Boston

(Sponsorship and relocation not available)

Required Skills ~ Minimum of 5 years of experience in quality assurance,manufacturing engineering, preferablya combination of both,within a manufacturing environment, with at least 2 years in a supervisory role.

As the Quality & Manufacturing Engineering Lead you will be joining a company focused on creating long-term career opportunities for all employees, project ownership, creative problem solving and individual development and recognition. This company understands that happy employees, provided with interesting and challenging work, are what makes success possible!

In this Quality and Manufacturing Engineering role you will lead the optimization of quality assurance and manufacturing engineering operations, focusing on product quality, process improvements, and regulatory compliance. This role is your opportunity to innovate and elevate our quality and manufacturing strategies while guiding a talented team. You'll drive Lean and Continuous Improvement initiatives to ensure that manufacturing processes are efficient, cost-effective, and meet the highest standards of quality. Your role will be pivotal in building and motivating a high-performing team, working collaboratively across departments to align and achieve our ambitious goals. Embrace this exciting challenge and make a significant impact on operational success in a dynamic and supportive environment.

Key Responsibilities:

• Quality Assurance: Oversee the development, implementation, and maintenance of quality control systems in compliance with ISO 9001 standards. Ensure products meet or exceed quality standards and regulatory requirements, leading efforts to identify and address quality issues and driving continuous improvement in product quality.

• Manufacturing Engineering: Lead and manage the manufacturing engineering function to optimize production processes. Drive the development and implementation of engineering solutions that improve manufacturing efficiency, reduce costs, and support new product introductions.

• Process Improvement:?Own and drive process improvements that enhance product quality, reduce waste, and improve overall manufacturing efficiency. Leverage the expertise of the Quality Engineer, Quality Inspector, and Manufacturing Engineer to identify and implement best practices.

• Team Leadership: Leada team of 1 Quality Engineer, 1 Quality Inspector, and 1 Manufacturing Engineer. Provide leadership, mentorship, and performance management to foster a collaborative, high-performance work environment.

• Root Cause Analysis:Lead investigations into product defects, process deviations, and production issues. Conduct root cause analysis and implement corrective and preventive actions (CAPA) to prevent recurrence and improve overall process reliability.

• Compliance & Documentation: Ensure all quality and manufacturing engineering activities comply with ISO 9001 standards, as well as other relevant industry regulations. Maintain accurate and thorough documentation of processes, inspections, testing, and engineering changes.

• Customer Focus: Act as the primary point of contact for customer quality concerns and engineering-related inquiries. Proactively address and resolve issues, ensuring customer satisfaction and maintaining strong relationships.

• Reporting & Metrics: Develop and maintain metrics to track quality and manufacturing performance. Report regularly on key performance indicators (KPIs) to senior management, driving data-driven decision-making.

• Cross-Functional Collaboration: Partner with Production, Supply Chain, and other departments to align quality and engineering goals with broader business objectives. Promote a culture of continuous improvement and quality excellence across the organization.

Requirements:

• Bachelors degree in Engineering, Quality Management, or a related field.

• Minimum of 5 years of experience in quality assurance, manufacturing engineering, or a combination of both within a manufacturing environment, with at least 2 years in a supervisory role.

• Required experience with ISO 9001 standards, including the development and maintenance of quality management systems.

• Proven experience and ownership in Lean/Continuous Improvement initiatives, with a track record of driving successful process improvements.

• Strong knowledge of root cause analysis, RCCA, CAPA, and process improvement methodologies.

• Proficiency in engineering and quality management software and tools. Experience with QT9 preferred.

• Strong leadership and team management skills with a track record of building and developing high-performing teams.

• Strong analytical and problem-solving skills, with the ability to interpret data and make data-driven decisions.

• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.

• Ability to thrive in a fast-paced, dynamic environment and adapt quickly to changing priorities and requirements.

• Ability to manage multiple priorities and adapt to changing demands.

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